Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

March 8, 2022 updated by: Gilead Sciences

A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
      • Hong Kong, Hong Kong
        • Prince Margaret Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital-HK
  • Korea, Republic of
      • Ansan, Korea, Republic of, 425-707
        • Korea University Ansan Hospital
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Ilsan, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 06591
        • Catholic University of Korea, Seoul Saint Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Groups 1-3 and 5:

    • Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment

  • Group 4:

    • HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
    • Have been on a commercially available HBV NUC treatment(s)

Key Exclusion Criteria:

  • Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
  • Extensive bridging fibrosis or cirrhosis
  • Evidence of hepatocellular carcinoma on imaging
  • Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
  • Chronic liver disease of a non-HBV etiology
  • Current alcohol or substance abuse

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Inarigivir Soproxil 50 mg + TAF
Viremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992
Drug: TAF
Administered orally once daily with food
Other Names:
  • Vemlidy®
  • GS-7340
EXPERIMENTAL: Group 2: TAF
Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks.
Drug: TAF
Administered orally once daily with food
Other Names:
  • Vemlidy®
  • GS-7340
EXPERIMENTAL: Group 3: Inarigivir Soproxil 200 mg + TAF
Viremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992
Drug: TAF
Administered orally once daily with food
Other Names:
  • Vemlidy®
  • GS-7340
EXPERIMENTAL: Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs
Virally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks.
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992
EXPERIMENTAL: Group 5: Inarigivir Soproxil 400 mg + TAF
Viremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992
Drug: TAF
Administered orally once daily with food
Other Names:
  • Vemlidy®
  • GS-7340

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
Time Frame: Baseline, Week 12
Baseline, Week 12
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
Time Frame: Baseline, Week 12
Baseline, Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time Frame: Baseline, Week 12
Baseline, Week 12
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time Frame: Baseline, Weeks 12, 24, 36, and 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Baseline, Weeks 12, 24, 36, and 48
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Time Frame: Baseline, Weeks 12, 24, 36, and 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time Frame: Baseline, Weeks 12, 24, 36, and 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.
Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Time Frame: Baseline, Weeks 12, 24, 36, and 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.
Baseline, Weeks 12, 24, 36, and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
Time Frame: Baseline, Week 48
Baseline, Week 48
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)
Time Frame: Baseline up to Week 12
Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits
Baseline up to Week 12
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time Frame: Baseline, Weeks 12, 16, 24, 36, and 48
Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time Frame: Baseline, Weeks 12, 16, 24, 36, and 48
Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Time Frame: Baseline, Weeks 12, 16, 24, 36, and 48
Baseline, Weeks 12, 16, 24, 36, and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

F-star Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Lim YS, Hui AJ, Jang JW, Tak WY, Ahn SH, Jang BK, et al. Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study [Abstract PO-2422]. The International Liver Congress: European Association for the Study of the Liver (EASL) Virtual; 2021 23-26 June.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 28, 2018

Primary Completion (ACTUAL)

January 20, 2020

Study Completion (ACTUAL)

January 26, 2021

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (ACTUAL)

February 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-464-4437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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